Regulatory Project Manager Jobs

Job Title: Regulatory Project Manager

Location: Remote

Duration: 12 Months +

Start Date: 7/10

Job Scope: Our client is looking for a 3-5 year Regulatory Project Manager who will work closely with the Associate Director of Regulatory Project Management in association with Regulatory Strategy and Operational teams, as well as cross-functional teams across the organization (i.e., Clinical, Nonclinical, and Quality) to build and manage timelines to support regulatory filings through licensure and beyond. The client is open to considering Regulatory Submission Managers with vast Regulatory Project Management experience. Global Experience is a must.

Responsibilities:

• Ensure creation of agendas, meeting minutes, and tracking/resolution of action items.
• Track and monitor timelines for key activities (e.g. database lock, document deliverables, authoring responses to health authority questions and meeting regulatory commitments).
• Proactively provide status updates to designated stakeholders via dashboards and milestone reports, and ensure leadership is aware of critical considerations
• Assist submission working group cross functional meetings to drive decision making and project execution.
• Assist to ensure roles and responsibilities for project team members are clearly documented.
• Assist to ensure overall regulatory project timelines are aligned cross-functionally and support the coordination of timely regulatory submissions.
• Assist to define, manage, and track specific deliverables needed for regulatory submissions working with cross-functional teams, including INDs/CTAs, BLAs/MAAs (Modules 1-5), meeting requests, briefing packages, responses to health authority requests, etc.
• Contribute to develop submission project timelines that identify key milestones to meet business objectives (e.g. from clinical trial initiation to regulatory submission and approval)

Skills:

• Global Experience
• IND / BLA / MAA / CTA
• Regulatory Project Management

Education:

• BS